MIV-818肝癌的治疗进入非临床发展

StephenW

Medivir: Medivir’s Nucleotide Polymerase Inhibitor for the Treatment of Liver Cancer, MIV-818, Enters Non-Clinical Development
November 01, 2016 10:57 AM Eastern Daylight Time

STOCKHOLM--(BUSINESS WIRE)--Regulatory News:

    “We are delighted to have delivered the first CD from our internal portfolio of early-stage anti-cancer and immuno-oncology projects since it represents an important milestone in our transition to being an exclusively oncology-focused pharmaceutical company.”
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Medivir AB (Nasdaq Stockholm: MVIR) (STO:MVIRB) today announces that MIV-818 has been selected as a candidate drug (CD) from its nucleotide DNA polymerase inhibitor project for the treatment of hepatocellular carcinoma (HCC), and has now entered non-clinical development.

Liver cancers are orphan indications in North American and Western European markets. However they are the second leading cause of cancer-related death worldwide, and one of the fastest growing forms of cancer in the US, based on incidence and mortality. Hepatocellular carcinoma (HCC) is the most common cancer of the liver. Despite improvements in the detection and management of the disease, the 5-year survival rate for patients in the USA who are diagnosed with liver cancer remains below 20%. While curative surgical treatments are available to HCC patients who are diagnosed early in their disease, the prognosis for all inoperable HCC cases remains poor. There is consequently an urgent need for improved treatments, particularly for patients with advanced stages of HCC and other forms of liver cancer.

Effective therapies for patients with inoperable intermediate HCC include the delivery of drugs directly to the cancer tumour through the liver’s blood supply, which is technically challenging and for which many patients are ineligible. In contrast, most anticancer drugs that are widely distributed throughout the body are ineffective. Sorafenib is the only orally administered drug used to treat liver cancer. It is approved for use in patients with advanced HCC but confers only modest survival benefits. Despite these limitations, sorafenib has achieved over $1B in annual worldwide sales across several cancer indications, with the majority of sales from treatment of HCC.

Medivir has developed substantial capabilities to selectively deliver the active metabolites of nucleoside and nucleotide analogues to the liver, based on its long-standing interests in discovering improved treatments for chronic hepatitis B virus and hepatitis C virus infections. MIV-818 is a potent and selective inhibitor of the proliferation of liver cancer cell lines that has been designed to deliver high levels of the active drug selectively to the liver. MIV-818 has the potential to become the first liver-targeted orally administered drug to address HCC and other liver cancers. Medivir expects to communicate the preclinical antitumour and pharmacokinetic profile of MIV-818 at major scientific meetings in 2017.

“MIV-818 is unique in that it is an orally administered chemotherapeutic that will be developed exclusively for liver cancers. Many treatments that were successful in other cancers have failed to provide benefits to liver cancer patients, often because systemic toxicity prevents effective drug concentrations from being reached at the tumour site. We have designed MIV-818 to be liver-directed in order to overcome these limitations, and we look forward to advancing it into clinical trials as rapidly as possible.” said Richard Bethell, Chief Scientific Officer, Medivir AB. “We are delighted to have delivered the first CD from our internal portfolio of early-stage anti-cancer and immuno-oncology projects since it represents an important milestone in our transition to being an exclusively oncology-focused pharmaceutical company.”

This information is information that Medivir AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the CFO set out above, at 15.45 CET on 1 November, 2016.

About Medivir

Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

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Contacts

Medivir AB
Ola Burmark, CFO
mobile: +46 (0) 725 480 580
or
Richard Bethell, CSO
mobile +46 (0)72 704 3211

StephenW

MIV-818肝癌的治疗进入非临床发展
Medivir：Medivir's Nucleotide Polymerase Inhibitor for the Treatment of Liver Cancer，MIV-818，Enters Non-Clinical Development
November 01，2016 10:57 AM Eastern Daylight Time

斯德哥尔摩 - （BUSINESS WIRE） - （美国商业资讯） - 监管新闻：

    “我们很高兴从我们的早期抗癌和免疫肿瘤项目的内部投资组合中提供了第一张CD，因为它是我们向成为一家以肿瘤为中心的专业制药公司过渡的重要里程碑。
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Medivir AB（Nasdaq Stockholm：MVIR）（STO：MVIRB）今天宣布，MIV-818已从其用于治疗肝细胞癌（HCC）的核苷酸DNA聚合酶抑制剂项目中被选为候选药物（CD），现在已进入非临床开发。

肝癌是北美和西欧市场的孤儿适应症。然而，它们是全世界癌症相关死亡的第二主要原因，并且是基于发病率和死亡率的美国增长最快的癌症之一。肝细胞癌（HCC）是肝脏最常见的癌症。尽管在疾病的检测和管理方面有所改进，但在美国被诊断患有肝癌的患者的5年存活率仍然低于20％。虽然治疗手术治疗可用于在其疾病早期诊断的HCC患者，但所有不能手术的HCC病例的预后仍然很差。因此，迫切需要改进的治疗，特别是对于晚期肝癌和其他形式的肝癌的患者。

对于不能手术的中间HCC的患者的有效治疗包括通过肝脏的血液供应直接向癌症肿瘤递送药物，这在技术上是有挑战性的，并且许多患者不合格。相比之下，广泛分布在整个身体的大多数抗癌药物是无效的。索拉非尼是用于治疗肝癌的唯一口服药物。它被批准用于具有晚期HCC的患者，但仅提供适度的存活益处。尽管有这些限制，索拉非尼已经在几个癌症适应症的年度全球销售中获得了超过$ 1B，其中大部分来自治疗HCC的销售。

基于其在发现用于慢性乙型肝炎病毒和丙型肝炎病毒感染的改善的治疗方面的长期兴趣，Medivir已经开发出将核苷和核苷酸类似物的活性代谢物选择性地递送到肝脏的大量能力。 MIV-818是肝癌细胞系增殖的有效和选择性抑制剂，其被设计为向肝脏选择性地递送高水平的活性药物。 MIV-818有可能成为第一个肝靶向口服药物，以解决HCC和其他肝癌。 Medivir希望在2017年的主要科学会议上传达MIV-818的临床前抗肿瘤和药代动力学特征。

“MIV-818的独特之处在于它是一种专门用于肝癌的口服化疗药物。在其他癌症中成功的许多治疗未能为肝癌患者提供益处，常常是因为全身毒性阻止在肿瘤部位达到有效的药物浓度。我们已经设计MIV-818是肝脏导向的，以克服这些限制，我们期待着尽快将其进入临床试验。“Medivir AB首席科学官Richard Bethell说。 “我们很高兴从我们的早期抗癌和免疫肿瘤项目的内部投资组合中提供了第一张CD，因为它是我们向成为一家以肿瘤为中心的专业制药公司过渡的重要里程碑。

此信息是Medivir AB根据“欧盟市场滥用法规”必须公开的信息。这些信息通过上述CFO的机构在2016年11月1日15.45CET提交出版。

关于Medivir

Medivir是一家以研究为基础的制药公司，其研究重点是肿瘤学和传染病。我们在蛋白酶抑制剂设计和核苷酸/核苷科学领域拥有领先的能力，我们致力于开发满足巨大未满足的医疗需求的创新药物。我们的商业组织在北欧市场提供专业护理药品组合。 Medivir在Nasdaq Stockholm中上榜上市。

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联系人

Medivir AB
Ola Burmark，首席财务官
手机：+46（0）725 480 580
要么
理查德贝塞尔，CSO
mobile +46（0）72 704 3211